News & Analysis as of

Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications

In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices. On March 3, 2014, the Food and Drug Administration (FDA) released a...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles

After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion. The agency...more

HHS-OIG Criticizes 340B Drug Discount Program

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more

Pennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties

On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face...more

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

Federal Court Finds Actavis Applies Only To Settlements Involving Monetary Payments

A United States district court judge sitting in the District of New Jersey has held that only patent litigation settlements involving monetary payments from branded to generic pharmaceutical manufacturers are subject to the...more

The District of Delaware Stops Exela’s Bid To Market Generic Orimev

In the District of Delaware, Judge Leonard Stark recently issued a final judgment and permanent injunction in Cadence Pharms., Inc. v. Exela Pharma. Scis., LLC, No 11-733, 2013 U.S. Dist. LEXIS 166097 (D. Del. Nov. 14, 2013),...more

Trade Secrets Trend To Watch In 2014: Government Regulations Requiring Public Disclosure Of Proprietary Information

In the New Year, one of the trade secret trends we’re watching is the ongoing tension between a company’s interest in preserving its proprietary information and the public’s demand to know more about the goods or services it...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

Manufacturers Face Potential Roadblock to Early Challenges to Biologic Drug Patents

Biologic drugs have become increasingly popular in recent years, and now serve as standard treatment options for diseases such as diabetes, anemia, cancer, hepatitis, and multiple sclerosis. Biologics are a class of drugs or...more

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

China Expects Major Changes in Drug Registration and Contract Manufacturing Rules

The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...more

Northern District of California Interprets the Biosimilars Act and Limits Declaratory Relief for Biosimilar Manufacturer: What You...

In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory...more

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

Major Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)

On September 28, 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204). The bill is compromise legislation crafted by the Senate Health, Education, Labor, and Pension ("HELP") and House...more

FDA Rule Change Could Hold Generic Drug Manufacturers Liable

In 2004, Nancy Bartlett, a secretary for a New Hampshire insurance company visited her doctor complaining of shoulder pain and was prescribed the non-steroidal anti-inflammatory drug Clinoril. Ms. Bartlett received the...more

Grassley Turns His 340B Microscope on Manufacturers

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers. As we previously wrote, Senator Grassley has been among the most vocal of critics in...more

A Double Play For Prescription Drug Manufacturers In The Eleventh Circuit

Consistent with the U.S. Supreme Court’s opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Eleventh Circuit recently held that generic prescription drug manufacturers cannot be held liable under state-law failure...more

Pharmaceutical Marketing

Drug manufacturers insist we all have our daily dose of DTCPA. ...more

Filing a Lawsuit Against Lipitor Manufacturers, Distributors & Marketers

It can take years for the public to find out about the dangers of pharmaceutical drugs. The main types of drug-related product liability claims arise from: - Defectively manufactured pharmaceutical drugs - Drugs...more

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

News from Abroad: UK High Court Considers quia timet Injunctions

The UK High Court recently gave its judgment in the case of Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva)...more

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